Medical devices and methods of use

ABSTRACT

Systems, and methods of disassembling systems that includes a medical device, a shaft that is optionally steerable, and a handle assembly. The methods can include providing a system after it has been exposed to a blood environment of a subject, disconnecting a medical device electrical contact from an electrical contact on the printed circuit board, moving the medical distally relative to the sheath and out of the distal end of the sheath, and cleaning at least a portion of the medical device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of International Application No.PCT/US2017/042859, filed Jul. 19, 2017, which claims priority to thefollowing U.S. Provisional Applications: U.S. Provisional ApplicationNo. 62/364,268, filed Jul. 19, 2016, and U.S. Provisional ApplicationNo. 62/404,711, filed Oct. 5, 2016, each of which are incorporatedherein by reference.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

BACKGROUND

A wide variety of intravascular medical devices are known. After themedical device has been used in a subject, it may be desirable to reusethat medical device, or at least a portion of the medical device inanother subject, rather than using an entirely new medical device, or anentirely new portion of the medical device. One reason for the desire toreuse at least a portion of the medical device can be the cost of atleast a portion of the medical device. Rather than buying a new medicaldevice or portion thereof, it may be less expensive to reuse the deviceor portion thereof again. If the device or a portion thereof has beenexposed to a bodily fluid (e.g., in a blood environment), the medicaldevice generally needs to be cleaned and re-sterilized (and perhapsdisassembled to some extent) before being used again in another subject.Some non-sellers of the device attempt to clean the device and thenresell it for subsequent uses. Downsides to this approach include thedevice being handled and cleaned by inexperienced individuals, who maydamage the device, rendering it unsafe for subsequent uses. There is aneed to have a more reliable, safe, and/or predictable practices inplace to reuse medical devices that have been exposed to bodily fluids(e.g., in a blood environments).

Additionally, there are limitations on the use of some medical devices,such as, without limitation, ultrasound imaging devices. Improvedsystems, devices, and methods that facilitate better control andusability of medical device are also needed.

SUMMARY

One aspect of the disclosure is a method of disassembling a systemexposed to a bodily fluid of a subject, the system including a medicaltool (optionally an ultrasound probe), a steerable shaft, and a handleassembly. The method includes: providing a handle assembly, a steerablesheath that has been exposed to a bodily fluid environment of a subject,and a medical tool (optionally an ultrasound probe) that has beenexposed to the bodily fluid environment of the subject, the handleassembly in operable communication with the steerable sheath and themedical tool, the handle assembly including a handle body with an outersurface that can be gripped by a user, a first actuator adapted to bemoved relative to the handle body, and a second actuator adapted to bemoved relative to the handle body, the steerable sheath having a distaldeflectable region that is in operable communication with at least onepull wire, wherein the first actuator is in operable communication withthe pull wire such that actuation of the first actuator relative to thehandle body causes deflection of the distal deflectable region, andwherein the second actuator is adapted to be rotated relative to thehandle body and is also adapted to be moved axially relative to thehandle body, and wherein the second actuator is in operablecommunication with the medical tool such that axial movement of thesecond actuator relative to the handle body causes axial movement of themedical tool relative to the distal end of the steerable sheath, andsuch that rotation of the second actuator relative to the handle bodycauses rotation of the medical tool relative to the distal end of thesteerable sheath, the medical tool having a distal portion that caninclude an ultrasound transducer, the distal portion extending furtherdistally than a distal end of the steerable sheath and having an outerdimension greater than a dimension of a lumen of the steerable sheath inwhich the medical tool is disposed, the medical tool further including aflexible circuit strip, the flexible circuit strip comprising aninsulating substrate, a plurality of conductive traces disposed on andextending along the insulating substrate, a portion of each of theplurality of conductive traces covered by an insulation member, and aportion of the plurality of conductive traces not covered by theinsulation member, the portion of the plurality of conductive tracesthat are not covered by the second insulation layer defining a contact,the contact electrically coupled to an electrical contact on a printedcircuit board.

The method can further include electrically disconnecting the contactfrom the electrical contact on the printed circuit board.

The method can further include moving the medical tool distally relativeto the steerable sheath and out of the distal end of the steerablesheath.

The method can optionally further include cleaning at least a portion ofthe medical tool, the portion comprising a region of the medical toolthat, prior to the moving step, does not extend outside of the steerableshaft and optionally comprises a region that, prior to the moving step,was disposed within the handle assembly. The method can optionallyfurther include, at some time after the cleaning step, electricallycoupling the contact to either the printed circuit board or a differentprinted circuit board.

In some embodiments of the method, the medical tool comprises aplurality of flexible circuit strips, each of the plurality of flexiblecircuit strips comprising an insulating substrate, a plurality ofconductive traces disposed on and extending along the insulatingsubstrate, a portion of each of the plurality of conductive tracescovered by an insulation member, and a portion of the plurality ofconductive traces not covered by the insulation member, the portion ofthe plurality of conductive traces that are not covered by theinsulation member defining a probe contact.

The method can further include, at some time before the moving step,releasing the medical tool from a releasably secured engagement with ahandle assembly component. Releasing the medical tool from a releasablysecured engagement with a handle assembly component can includereleasing the probe from a releasably secured engagement with a handleassembly component that is in direct or indirect operable communicationwith the second actuator.

One aspect of the disclosure is a method of removing a used electricalcontact from a flexible circuit. The method can further include creatingor preparing a new electrical contact on the flexible circuit from whichthe used electrical contact was removed.

One aspect of the disclosure is reusing a flexible circuit after a firstelectrical contact has been used and is not being used anymore to createan electrical connection. The first electrical contact can optionally beremoved after its use.

One aspect of the disclosure is a method of removing an electricalcontact from an ultrasound probe to reuse the ultrasound probe,comprising: providing an ultrasound probe that has an ultrasoundtransducer in a distal region, wherein the ultrasound probe includes atleast one exposed region of a plurality of conductive traces, theexposed region defining a probe contact; and disconnecting the probecontact from the ultrasound probe.

Disconnecting the probe contact from the ultrasound probe can comprisecutting the probe contact from the ultrasound probe. The method canfurther comprise exposing the plurality of conductive traces in a newregion in which they were previously unexposed, the new region defininga new probe contact. Exposing the plurality of conductive traces in anew region can comprise any of the following: removing an adhesive layerfrom the ultrasound probe contact, ablating a portion of an insulationcovering the conductive traces, using a laser to ablate away a region oninsulation material, and dissolving at least a portion of insulationmaterial with a solvent. The method can further comprise electricallycoupling the new probe contact to an electrical contact on a printedcircuit board.

One aspect of the disclosure is a flexible circuit that includes a firstelectrical contact, and also includes at least one additional electricalcontact that can be created or prepared on the flexible circuit for useafter the first electrical contact has been used and is not being usedanymore to create an electrical connection.

One aspect of the disclosure is a flexible circuit strip, comprising: anelongate substrate; a plurality of elongate conductive traces disposedon and extending along the substrate; first and second covering elementsdisposed on and covering the plurality of conductive traces, wherein thefirst and second covering elements are axially separated from eachother, and wherein the first and second covering elements definetherebetween a new probe contact comprising the plurality of conductivetraces; and a removable covering element disposed over the new probecontact, the removable covering element adapted to be removed from theplurality of conductive traces to expose the plurality of conductivetraces at the location of the new probe contact.

The strip can further include at least a third covering element disposedon and covering the plurality of conductive traces, and axially spacedfrom the second covering element, the second and third covering elementsdefining therebetween a second new probe contact, and a second removablecovering element disposed over the second new probe contact, the secondremovable covering element adapted to be removed from the plurality ofconductive traces to expose the plurality of conductive traces at thelocation of the second new probe contact.

One aspect of the disclosure is an integrated medical tool, comprising:a handle assembly, a steerable sheath, and a medical tool (optionally anultrasound probe), the handle assembly in operable communication withthe steerable sheath and the medical tool, the handle assembly includinga handle body with an outer surface that can be gripped by a user, afirst actuator adapted to be moved relative to the handle body, and asecond actuator adapted to be moved relative to the handle body; thesteerable sheath with a distal deflectable region that is in operablecommunication with at least one pull wire; and an elongate medical toolwith a distal portion that comprises a working end (optionally anultrasound transducer), at least a portion of the elongate medical tooldisposed within the steerable sheath, the elongate medical tool inoperable communication with the second actuator, wherein the firstactuator is in operable communication with the at least one pull wiresuch that actuation of the first actuator relative to the handle bodycauses deflection of the distal deflectable region, and wherein thesecond actuator is adapted to be rotated relative to the handle body andis also adapted to be moved axially relative to the handle body, andwherein the second actuator is in operable communication with theelongate medical tool such that axial movement of the second actuatorrelative to the handle body causes axial movement of the elongatemedical tool relative to the distal end of the steerable sheath, andsuch that rotation of the second actuator relative to the handle bodycauses rotation of the elongate medical tool relative to the distal endof the steerable sheath.

The second actuator can interface with the handle assembly such that theinterface with the handle assembly restricts at least one of thefollowing: axial movement of the second actuator in both the proximaland distal directions within a fixed range of motion, and rotationalmovement of the second actuator in both directions of rotation within afixed range of motion.

The first actuator can be adapted to be rotated relative to the handlebody such that rotation of the first actuator relative to the handlebody causes deflection of the distal deflectable region.

The medical tool can extend further proximally than a proximal end ofthe steerable sheath and optionally further proximally than the handlebody.

In some aspects the disclosure herein relates to medical devices,systems, apparatuses, and their methods of use, methods of assembly, anddisassembly. In some embodiments, the disclosure relates to steerablemedical devices, or at least medical devices that are steered via aseparate steerable shaft. Steerable devices, as that term andderivatives of that term are used herein, include any type of medicaldevice that may benefit from being steered, bent, or deflected, directlyor indirectly.

In some aspects the disclosure relates to steerable medical tools. Whena steerable medical tool is described herein it is merely an example ofthe steerable medical devices described herein. Steerable deliverydevices can be used to deliver, or guide, any type of suitable medicaldevice or instrument therethrough to a target location within apatient's body. For example, a steerable delivery device can be used todeliver, or guide, a medical device into body lumens or cavities suchas, for example without limitation, a blood vessel, an esophagus, atrachea and possibly adjoining bronchi, any portion of thegastrointestinal tract, an abdominal cavity, a thoracic cavity, variousother ducts within the body, the lymphatics, one or more chambers of theheart, etc. Once a steerable medical device has gained access to atarget location within the subject, the tool can be used to carry outone or more medical interventions. In some methods of use, the steerabledevice described herein is tracked along a previously positioned guidewire, the positioning of which is known in the art. In some embodimentsthe steerable concepts described herein can be applied to steerablemedical tools such as catheters that have any diagnostic and/ortherapeutic functionality.

In some embodiments herein, a medical device (which may also be referredto herein as a medical tool or tool) is integrated with a steerablesheath prior to delivery of the medical device to target tissue. Forexample, a medical device may be integrated with any of the steerablesheaths herein.

As used herein, a medical device or tool can be any type of medicaldevice, including devices with diagnostic and/or therapeuticfunctionality. Integrated medical devices include catheters configuredto provide functionality using at least a distal working region. Acatheter with a distal tip electrode and associated components extendingalong its length is a mere example of a medical device that can beintegrated with steering capabilities herein. A device with one or moreultrasound transducers, optionally for ultrasound imaging, can be any ofthe medical tools herein.

Another aspect of the disclosure relates to electrical connectionsbetween a connector and contacts that are in electrical communicationwith a working region, optional at a distal end, of a medical device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates an exemplary embodiment of a system that integratessteering and a medical device.

FIG. 1B illustrates a cross section A-A of the steering and deviceportion of the medical device of FIG. 1.

FIG. 2 illustrates an exemplary integrated system that includes a handleassembly with a plurality of actuators, a steerable sheath and medicaltool.

FIGS. 3 and 4 illustrate an exemplary embodiment of a system in whichthe steerable portion can have a cross section equal to that shown inFIG. 2.

FIGS. 5 and 6 illustrate exemplary distal regions of a system in whichthe steerable portion can include a cross section as illustrated in FIG.1B.

FIG. 7 illustrates a system comprising a medical tool inside a steerablesheath, designed to have modular components that are provided to theuser in an integrated manner.

FIGS. 8A and 8B illustrate an embodiment where a sheath handle includesa removable or breakable handle portion.

FIGS. 9A and 9B illustrate a portion of an exemplary system in which atool lock and handle are configured to limit the range of medical devicerotation.

FIGS. 10A and 10B illustrate an embodiment of a system that includes asteerable sheath that has exemplary modular features to aid in reposingthe device.

FIGS. 11A and 11B illustrate an alternative embodiment of a systemwherein a tool lock is contained within a sheath handle but coupled toan outer control.

FIGS. 12Ai, 12Aii, 12Bi, 12Bii, and 12C illustrate a concept where amedical tool contains a proximal electrical connector containing aplurality of electrical contacts.

FIGS. 13A, 13B and 13C illustrate an exemplary proximal coupling betweena medical tool and a connector.

FIGS. 14A and 14B illustrate an exemplary system with a connector thatcontains an inner feature designed to enclose a tool lock attached to atool portion.

FIG. 15 illustrates an exemplary system that includes a separate torquedevice that could be attached to a medical tool to provide an ability totranslate and torque the tool relative to a steerable sheath.

FIGS. 16A, 16B and 16C illustrate an exemplary tool that comprises anouter member and an inner lead assembly.

FIG. 17 illustrates an exemplary portion of an exemplary system thatincludes a bundle.

FIG. 18 illustrates an exemplary proximal end of a medical tool, thetool including a conductor bundle that extends into a proximal connectorwithin which is housed a printed circuit board (PCB).

FIG. 19A illustrates a portion of an exemplary medical tool thatincludes a flexible circuit strip.

FIG. 19B illustrates an exemplary proximal portion of a strip.

FIG. 19C illustrates a detailed view of an exemplary proximal portion ofa strip.

FIG. 19D illustrates an end view of an exemplary flex strip.

FIG. 19E illustrates an exemplary stack of flex strips.

FIG. 19F illustrates an exemplary stack of flex strips and ground andshield strips.

FIG. 19G illustrates an exemplary bundle including a tubing materialaround a stack of strips and shield and ground strips.

FIGS. 20A and 20B illustrate an embodiment in which a plurality of flexcircuit strips have a staggered length and exposed locations areattached to a PCB at contacts provided in a similarly staggered length.

FIG. 20C illustrates an exemplary method of moving a tool distally andout of a sheath, optionally a steerable sheath.

FIG. 21 illustrates an exemplary embodiment in which a conductor bundlecan be reversibly spooled or wrapped around a spool comprising a rod,tube, spindle or similar rotatable structure.

FIG. 22 illustrates a portion of an exemplary embodiment in whichexposed flex circuit ends are attached to a disposable mini-PCB elementwhich has a same size connection on one side, but a larger exposedconnection on the opposite side.

FIGS. 23, 24, 25, 26, and 27 illustrate alternate exemplary embodimentsof cross-sections of a bundled stack in a lumen, which can beincorporated into any the systems herein.

DETAILED DESCRIPTION

FIG. 1A illustrates an exemplary embodiment of a system that integratessteering and a medical device. System 1000 includes handle assembly 1002and steering and medical device portion 1004. Steering and medicaldevice portion 1004 includes a proximal portion 1006 and steerableportion 1008. The system is adapted so that handle assembly 1002 can beactuated to cause steering of the steerable portion 1008, and optionallycan be further actuated to cause movement of medical device 1010relative to steering and medical device portion 1004. In this exemplaryembodiment, handle assembly 1002 includes first actuator 1001, secondactuator 1003, and third actuator 1005. First actuator 1001 is adaptedto be actuated (in this example rotated) relative to handle body 1007 tocause the steering of steerable portion 1008, and specifically steeringouter sheath 1102. Steerable portion 1008 in this embodiment can besteered, or bent, into the configuration shown in FIG. 1A in solidlines, and can also be steered into the configuration shown in dashedlines, or anywhere in between, and in some embodiments the oppositesteering function is limited to simply straightening the shaft from aninitial bent configuration, such as the solid line bent configuration inFIG. 1A. The term “steer” in this disclosure means to deflect or bend,optionally via actuation of at least one pull wire, but in someinstances the term can include shaft rotation (torquing) and axialmovement. The term “pull wire” herein refers to any element that maytransmit a tensile force from the proximal end of the device to thedistal end region. Pull wires may be comprised of metal wire such asstainless steel or nickel titanium, either solid or stranded/braided, orit may be comprised of a polymer such as Kevlar, polyethylene, ptfe,eptfe, etc., preferably stranded/braided, but also in monofilament form.The wire cross-sectional diameter can be in the 0.005″-0.012″ range,although braided or stranded wire may flatten or ovalize in the devicelumen. Optional second actuator 1003 is adapted to be actuated relativeto handle body 1007 (in this example rotated) to cause rotation ofmedical tool 1010 relative to shaft 1102 (labeled as rotation movement“R”), and optional actuator 1005 is adapted to be actuated relative tohandle body 1007 (in this example axially) to cause axial(distal-proximal) movement of medical device 1010 relative the outersheath 1102. Proximal portion 1006 is not configured to bendsignificantly when steerable portion 1008 is steered (bent/deflected),although the proximal portion may flex and bend to conform to theanatomy within which it is used. In many embodiments, this isaccomplished by constructing the steerable portion 1008 from a softer orless rigid material and/or composite construction than the proximalportion 1006.

The embodiment shown in FIG. 1A is an example of an apparatus thatincludes an integrated handle assembly that is in operable communicationwith both a steerable outer shaft and an inner medical tool. The handleassembly is integrated in that it is assembled and constructed to be inoperable communication with the outer shaft and the inner medical toolprior to packaging and use. “Integrated” as that term is used in thecontext of an integrated handle assembly refers to a handle assembly inwhich at least one part of the handle assembly has to be broken or takenapart before the medical tool can be removed from within the outershaft.

FIG. 1B illustrates an exemplary cross section A-A (shown in FIG. 1A) ofthe steering and device portion 1004, and specifically in the steerableportion 1008. In this embodiment medical device 1010 is sized andconfigured to be disposed within a steerable sheath. The steerablesheath includes an outer shaft 1102 and a set of pull wires 1104, whichare axially fixed in a distal region of steerable portion 1008.

The medical tool in FIGS. 1A and 1B can be, for example, any medicaltool herein, such as an ultrasound tool. When “ultrasound probe” is usedherein, it generally refers to an elongate tool that includes at leastone ultrasound transducer and one or more conductive elements thatelectrically connect the at least one ultrasound transducer to aproximal region of the elongate tool. A proximal region of theultrasound probe includes, or is modified to include, at least oneproximal contact, which is in electrical communication with the at leastone ultrasound transducer, and which can be put into electricalcommunication with, optionally via attachment to, an electrical contacton another device, cable, or connector.

FIG. 2 illustrates an exemplary system 10 that is adapted to functionsimilarly to the system in FIGS. 1A and 1B, and also illustratesexemplary internal components of handle assembly 12 (internal componentsshown as dashed lines). Handle assembly 12 is integrated and in operablecommunication with outer steerable shaft 20 and medical tool 30. Handleassembly 12 includes actuator 14 that is adapted to, when actuatedrelative to handle body 15, cause steering of steerable shaft 20.Actuator 14 is in operable communication with steerable shaft 20 viasteering control 16 disposed in handle assembly 12. Medical tool 30includes a proximal portion 18 disposed within and incorporated intohandle assembly 12. Actuator 13 is in operable communication withmedical tool 30, and actuation of actuator 13 (in this example rotation)relative to handle body 15, causes rotation of medical tool 30 relativeto outer shaft 20 via rotation control 1215. Optional third actuator 17is also in operable communication with medical tool 30, and is adaptedto be actuated, in this embodiment, axially (relative to handle body15), to cause axial movement of medical tool 30 relative to outersteerable shaft 20 via axial control 1217.

The medical tool in FIG. 2 can be, for example, any medical tool herein,such as an ultrasound tool.

FIGS. 3 and 4 illustrate an exemplary embodiment of a system 1200 inwhich the steerable portion can have a cross section as shown in FIG.1B. System 1200 includes steerable portion 1202 and medical tool 1204,both of which are configured to interface with each other. Steerableportion 1202 includes handle portion 1206 and a sheath portion 1208,which includes steerable portion 1222. Sheath portion 1208 includes anouter tubular member 1207. Medical tool 1204 includes handle portion1210 and tool portion 1212, which includes at least one shaft and aworking distal region at its distal end. Handle portion 1206 includessteering actuator 1220, which in this embodiment is adapted to berotated relative to handle body 1209 to cause the steering of steerableportion 1222.

Medical tool 1204 is configured to be advanced through steerable portion1202, both of which are configured to interface with each other. Whenadvanced, tool portion 1212 of medical tool 1204 is advanced throughsheath portion 1208 until its distal end is near the distal end ofsheath portion 1208, and a portion of handle portion 1210 is advanceddistally within handle portion 1206. Handle portion 1210 of medical tool1204 includes handle 1214 and stabilizer 1218. Stabilizer 1218 isconfigured, along with an internal portion of handle portion 1206, tointerface one another in a secure relationship to prevent relativemovement therebetween in at least one direction. Handle portion 1210also includes nut 1216, which is configured to interface with a proximalend of handle portion 1206. Stabilizer 1218 acts as an axial constraintfor medical tool 1204, relative to steerable sheath 1202.

As shown in FIG. 4, a distal working region of tool portion 1212 isextending distally out of sheath portion 1208 when the medical tool 1204and steerable sheath 1202 are stably interfacing with one another. Inthis embodiment the distal end of tool portion 1212 is not axially fixedrelative to the distal end of sheath portion 1208.

The medical tool in FIGS. 3 and 4 can be, for example, any medical toolherein, such as an ultrasound tool.

Handle 1214 can optionally include at least one actuator that can causethe axial and/or rotational motion of the medical device relative to thesteerable sheath. Thus, once the tool and sheath are stably interfaced,one or more tool handle actuators can control motion of the medical tool(e.g., rotational or axial). The tool and sheath can be interfaced afterpackaging and just prior to use, or they can be integrated beforepackaging. Handle 1214 can also include other controls that control thefunctionality of the medical tool.

FIGS. 5 and 6 illustrate an exemplary distal region of a steerablesystem that includes an inner medical tool. System 1300 includessteerable sheath 1302 and medical tool portion 1304. Steerable sheath1302 includes outer member 1308 and one or more pull wires 1306, whichare fixed distal to the steerable portion and configured such that, whena handle actuator is actuated, they are moved axially proximal to thesteerable portion, which causes their relative axial movement in thesteerable portion, which causes the steerable portion to be steered (asis described above). Pull wire 1306 can be parallel to the central axisin the steerable portion of the sheath.

In this merely exemplary embodiment, tool portion 1304 includes anelongate medical tool 1310 that includes an RF tip electrode at itsdistal end, and a guidewire lumen 1312, but the medical tool can be anyother medical tool herein. In this embodiment tool 1310 and steerablesheath 1302 are configured so that the tool distal end (including theregion very near the distal end) is axially immovable but rotationallymovable relative to the steerable sheath 1302 distal end (including theregion very near the distal end). To make the parts axially immovableand rotationally movable, outer member 1308 includes an extension 1314that extends radially inward relative to the inner surface of outermember 1308 proximal to extension 1314. Tool 1310 includes a region withan outer configuration 1315 (radially inwardly shaped) that correspondsto the extension 1314. The two components similarly have shaped elements1317 and 1318 distal to elements 1314 and 1315. The configuration of thetool and outer member therefore prevents distal and proximal movement ofthe tool relative to the outer member and therefore the steerable sheathwhen the tool and sheath are interfaced as shown. In this embodimenttool 1310 is rotationally free, or moveable, relative to steerablesheath. That is, while tool 1310 cannot move axially at the fixationlocation (which is distal to the steerable portion) it can be rotated.Being rotationally free can be beneficial if the medical tool, includingone or more instruments thereon, should be oriented in or facing aparticular direction.

Because the tool and the sheath are axially fixed distal to thesteerable portion, the proximal end of the tool is configured to be ableto move slightly axially during steering. For example, a spring builtinto the handle can allow the tool shaft to move slightly relative tothe steerable sheath. Other ways of allowing for proximal axial movementcan be incorporated as well.

The proximal end of system 1300 can include the two handle componentssuch as those shown in the embodiment in FIGS. 3 and 4, and can besimilarly interfacing, with the exception of the moderate axial movementof the tool at the proximal end.

In other embodiments the distal region shown in FIGS. 5 and 6 can beincorporated with a handle assembly shown in FIG. 1A or 2.

One aspect of the disclosure is a method of rendering two co-axialcomponents that were previously axially movable axially immovable(axially fixing them). This aspect also includes methods of removing theaxial fixation such that the components can again be axially moved. Thiscan be considered releasable axial fixation. The axial fixation iscreated, in general, prior to advancing the system into a patient, andin some embodiments the axial fixation is created during manufacturing.The release of the axial fixation can occur during a refurbishingprocess, and the axial fixation can again be created during arefurbishing process.

In some embodiments the system can be modified to include a componentwhose volume can be modified (increased or decreased) to cause the axialfixation of the medical tool. In some embodiments the component has aconfiguration that changes to cause the axial fixation of the medicaltool.

In some embodiments system 1300 is adapted so that extension 1314 isconfigured such that its volume can be modified to cause or release theaxial fixation. In this particular modification, fillable annular volume1319 (shown and labeled only once in the cross-section but it isunderstood that it exists on the other side due to its annularconfiguration) is adapted to be filled with a filling material, and suchthat the filling material can be removed as well. In these alternativeembodiments the outer member includes an annular filling volume 1319defined by the radially outer dotted line surface and by the radiallyinner portions of the previously described extension 1314. That is,extension 1314 is modified to include a fillable annular chamber orvolume 1319, but outer surfaces of extension 1314 remain and define theannular fillable volume 1319.

When it is desired to allow tool 1310 and sheath 1302 to be relativelyaxially movable, such as during manufacture of the system, fillablevolume 1319 remains at least partially un-filled, so that tool 1310 canbe easily advanced or retracted axially within sheath 1302. When it isdesirable to render tool 1310 and 1302 axially immovable, or fixed,(after they are in desired relative axial positions—such as duringmanufacturing or refurbishment), fillable volume 1319 is filled with afilling material so that the extension extends radially inward andbecomes more rigid, preventing the axial movement of tool 1310 relativeto sheath 1302. The extension in this embodiment is thus areconfigurable axial restraint.

If it is desirable to axially move the tool 1310 and sheath 1302 at alater time (such as during refurbishment—e.g., at least one of cleaningand sterilizing), the fillable material can then be removed from volume(or chamber) 1319, making extension less rigid, so that tool 1310 can beaxially moved relative to sheath 1302.

In these alternative embodiments extension 1314 can be consideredexpandable and unexpandable; fillable and unfillable; reconfigurable;configured and adapted to have a stiffness that can be modified;configured so that its rigidity can be modified; and having a volumethat can be modified.

In some embodiments the fillable material can be inserted and removedfrom annular fill volume 1319 with a fill device such as a needle.

In one exemplary use, tool 1310 is axially advanced to the position inFIG. 6, and fill volume 1319 is thereafter filled with a filing materialto axially fix tool 1310 and sheath 1302 (e.g., during manufacture orrefurbishment). The method can also include removing the fillingmaterial and axially moving at least one of the tool 1301 and sheath1302 (e.g., during refurbishment).

In an exemplary embodiment the filling material can be modified from asolid to liquid, and visa-versa, by changing its temperature. In someembodiments the fillable (also referred to herein as “filling”) materialis solid at operating temperature to increase the volume or rigidity ofextension 1314, but can be melted (or made less viscous) to allow it tobe removed from annular volume 1319.

In some embodiments the filling material is a wax. The wax can, in someembodiments, have a melting point less than a polymeric material of anadjacent component, such as an inner or an outer member.

This concept of creating axial fixation (and allowing removal of theaxial fixation) by, for example, adding and removing a filling material,can be used to axially fix any two components herein, including an outersheath of a steerable sheath and the medical tool within it.

FIG. 7 illustrates a system 1400 comprising a medical tool 1204 disposedpartially inside a steerable sheath 1202. Medical tool 1204 and sheath1202 can be any of the medical tools and sheaths described herein, eventhough they are labeled 1204 and 1202. While the steerable sheath 1202is preferably “steerable”, for example through the use of a pull wire orother functional deflection mechanisms (any of those set forth herein),it is understood that this “steerable” sheath (or any steerable sheathherein) could also be non-steerable in that it is just a straighttubular element, or has a fixed, non-deflectable distal curve shape.Steering may be also accomplished via torquing the sheath, with orwithout use of a deflection mechanism.

The system 1400 illustrated in FIG. 7 is designed to have modularcomponents that are provided to the user in an integrated manner, butwhich can be disassembled after a procedure using a specialized processto clean, repair, and/or replace any of the modular components of thesystem. The system 1400 may then also be reassembled, sterilized andrepackaged. This process, or in some cases a portion of this process,can be referred to herein as “reposing,” or “refurbishment,” and anysystem herein can be reposed or refurbished using any of the methodsherein. The performance of system 1400 is optimized for the medical tool1204 and sheath 1202 to work only with one another and not substituteother devices on the market that may have a similar function. Also, thereposing of the devices takes special care to ensure the continuedsafety and performance quality of the system.

In the disclosures that follow, many references are made to ways ofseparating various modular components of a system, either by breaking orusing a controlled process. Depending on the embodiment, handle portion1960 (see FIGS. 8A and 8B), rear handle 1961 (see FIG. 10), and handlelip 1962 (see FIG. 11A) can be separated from the handle assembly. Toollock 1955, for example, can be separated from tool portion 1212 ofmedical tool 1204 or from handle assembly 1206. Tool connector 1210 (seeFIG. 7) or 1990 (see FIG. 12A), for example, could be separated fromtool portion 1212. Hemostasis valve 1950 assembly (see FIG. 7) could beseparated from the handle assembly 1206. Sheath portion 1208 could beseparated from handle assembly 1206. Outer member 2010 (see FIG. 16B) oftool portion 1212 could be separated from inner lead assembly 2011 andits internal electrical connections. Many similar controlled processesand materials could be used to enable the initial assembly andsubsequent disassembly and reassembly of the components of any of theembodiments herein.

Any given process or combination of processes could be used at any oneor all the aforementioned modular separation points. The processesinclude but are not limited to the following examples. Components couldbe bonded using a material that acts like an adhesive or mechanicallock, but which can be deformed with heat to remove the components. Thisincludes materials such as wax and thermoplastic elastomers(polyurethane, polyethylene, polyamide, to name just a few). Materialssuch as hydrogels (such as those described previously herein) may beswollen with aqueous solutions to change their properties such that theysoften or become lubricious enough to separate components. Sugar, salt,starch, or other similar materials in crystal or powder form could beused to create a mechanical interference fit between components, butthen readily dissolved in an aqueous solution to separate thecomponents. These materials could also be used as a matrix in anon-degradable material that then compresses like a foam once thecrystalline structure is dissolved. Other polymers known to break downover time after contact with fluid (such as that introduced during use),including those also known in the art to be biodegradable, could be usedin the system such that replacement due to their weakened propertieswould be mandated. Other materials could be used that lose their holdingstrength in the presence of a chemical solvent. Strong acids or basescould be used to dissolve certain metals and plastics. For example,silicone may swell and tear easily in the presence of heptane, hexane,or isopropyl alcohol. Where a liquid material is to be dispensed toalter the seal, the seal could be protected during use inside aprotective space which can only be accessed with a special tool (such asa needle puncture diaphragm or luer activated valve).

Certain components may be joined using a solder or solder-like process,where reheating the solder will separate the components. In someembodiments the metallic joint could be separated using electrolysis.Mechanical interference could also be used to hold components together(e.g., screws, pins, thread, wedge, and the like). Ratcheting mechanisms(e.g., Zip-ties, belt-loop styles, roller-wedge, cam-actuated grips)could also be used to hold components together but require amanufacturer access to the parts to break and replace or use a tool totemporarily separate the components. Components could be held in placethrough magnetic attraction (magnet to magnet or magnet to iron). Inparticular embodiments, the magnetic hold could not be released withoutdemagnetizing the magnets. This could be accomplished by physicalbreaking or mechanically fatiguing the magnet, raising the temperatureof the magnet above its Curie Point (e.g., 80° C. for neodymiummagnets), or applying an alternating current across the magnet todisrupt the dipoles. In another embodiment, parts could be engaged andheld in place with a lock such as a bar fit into a hole or other capturefeature (similar to a door lock). The bar could be heat set in a curve,or a hinge structure, that is normally engaged in the hole, but uponexposure to heat beyond a transition temperature, changes shape to backout of the hole (allowing parts to be disassembled). In a similarmanner, the bar could be magnetized and when exposed to a magneticfield, forced out of the hole. Other similar mechanisms could use coilsor other springs, or spring-actuated devices, which change shape in thepresence of heat or a magnetic field to unlock. In another embodiment,components could be held together under hydraulic pressure (e.g., wateror oil such as mineral oil or silicone oil), such as a sealed cylinderwith a piston, a bellows, diaphragm, balloon, etc. To separate thecomponents, the pressure may be vented by puncturing into or otherwisebreaking the seal to the pressurized chamber. Opening or relaxing avalve to relieve the pressure could also be employed. In many cases, theprocess used to separate the parts will also contaminate or damage themenough to require replacement, further repair, and/or additionalcleaning before reassembly and other subsequent processing steps.

Any combination of the exemplary processes above could also be used.

In any of the embodiments herein, a medical tool can be an ultrasounddevice, with one or more ultrasound transducers disposed at its distalregion. For example, the ultrasound device may be an ultrasound imagingdevice, such as a 4D-ICE (intracardiac echocardiography) imaging tool.

FIG. 7 illustrates that tool portion 1212 of the medical tool 1204 maybe rotatable within and relative to steerable sheath 1202 and may alsobe optionally capable of axial translation within the sheath. Tool lock1955, which in FIG. 7 is disposed within the body of handle 1206, issecured to tool portion 1212 and may have one or more functions toconstrain movement within sheath 1202 and/or control the functionalityof medical tool 1204. FIG. 7 also illustrates a hemostasis valveassembly 1950 within the handle portion 1206 which is useful to keepblood or other fluids from leaking out from the proximal end ofsteerable sheath 1202, and to allow flushing of the luminal spacebetween tool 1204 and the inner lumen of sheath 1202.

FIGS. 8A and 8B illustrate another embodiment of a system where handleassembly 1206 includes a removable or breakable handle portion 1960 thatcan be removed from handle assembly 1206 or broken from assembly 1206 toallow access to an interior space of handle assembly 1206. Once removedor broken, as shown in FIG. 8A, access is available to tool lock 1955disposed with handle assembly 1206. Tool lock 1955 can then bedisassociated from tool portion 1212. As shown in FIG. 8A. Once toollock 1955 is removed, tool 1204 is can then be removed from sheath 1202,as shown in FIG. 8B.

In some embodiments, handle portion 1960 (and any other handle portionherein that can be removed or broken from a handle assembly) can beconfigured to interface with a corresponding component of handleassembly 1206 so that it can be stabilized relative to 1206 when in use,but can be removed from handle 1206 in a controlled manner withoutbreaking an interface between handle 1206 and portion 1960. For examplewithout limitation, the two parts could have a threaded interface.Alternatively, for example, portion 1960 can be configured so that theinterface between it and handle assembly 1206 must be broken, butwherein the interface is such that breaking it can be done in arelatively easy and predictable manner.

One function of tool lock 1955 is to prevent removal of the medical tool1204 from sheath 1202 to ensure system integrity as previously stated. Atool lock also limits the axial translation of the medical tool withinthe handle assembly by being physically constrained within the handleassembly. This may be desirable to ensure the medical tool is either notmoved axially, or the movement is constrained to a safe and functionalrange for the medical tool beyond the tip of the sheath. In anotherembodiment, illustrated in FIGS. 9A and 9B, tool lock 1955 and handleassembly 1206 may both be configured to limit the range of medical toolrotation. This may be desirable to prevent a build-up of torque in onedirection that could twist and damage portions of the outer member 2010or an inner lead assembly 2011 (see FIG. 16).

As illustrated in FIGS. 9A and 9B, tool lock 1955 has a feature 1956, inthis embodiment a radial protrusion on one side, that allows it to berotated through an angle less than 360° in either direction. Handleassembly 1206 has a protrusion extending radially inward that ispositioned and configured to engage with and stop movement of feature1956, and thus tool lock 1955. Other torque limiters known in the art,including those that limit torque to a finite number of full rotationsin a given direction, could also be employed. Axial travel and torquecould also be limited by opposing magnets. Resistance would beencountered as a magnet in a tool lock approached (via axial orrotational travel), an opposing magnet positioned in the handle portion.Rotational limitation, an illustration of which is shown FIGS. 9A and9B, can be incorporated into any of the systems herein.

In embodiments that include a tool lock, the tool lock rotational and/oraxial movement may also have a friction fit with features within thehandle such that it is moveable but does not rotate or slide back to theoriginal position except by action of the user. For example, either orboth the outer surface of the tool lock and an inner surf ace of thehandle portion (such as handle portion 1960) may comprise a lubriciousmaterial such as PTFE, FEP, Delrin (Acetal). Unless formed from the samematerial, the mating material could be a smooth polished polymer ormetal. The two parts could have a precise clearance or interference of,for example, up to 0.0002″. The friction could also be controlled by aslight interference from just a portion of the surface of the tool lockwith a portion of the handle portion (such as portion 1960). Theinterference could be a small integrated feature, and/or or a separatecomponent which is mounted on an elastic material such as a compressiblepolymer (silicone, polyurethane, etc.), either solid or in foam form, ora metal or rigid polymer spring formed from a coil or flat ribbon. Aslidable wedge could also be used to adjust the compression. The amountof compression interference could also be adjusted at the time ofmanufacture with a lead screw or a pressurized chamber driving theinterference features together. During a reposing process thiscompression friction interference would need to be disassembled, andthen reassembled and returned to manufacturer settings. In anotherembodiment, the compressive features could be assembled into the handleportion (such as portion 1960) to act directly on the tool portion 1212without the need for the tool lock feature. While the tool lock isillustrated as integrated into tool portion 1212, it could also beintegrated directly in to the tool handle portion 1210, which would beengaged into the sheath handle portion 1960. This is particularlyapplicable where axial translation of the medical tool 1204 relative tothe sheath 1202 is not required.

Tool lock 1955 may also have an electronic or electromagnetic featurewhich senses the presence of handle portion 1960 (or other handleportion). Once a handle portion (e.g., portion 1960) is removed, thetool lock may disable the functionality of medical tool 1204. Forexample, the handle portion may include a magnet mounted in proximity tothe tool lock. The magnet can hold a reed switch closed in the tool lockthat completes a functional circuit in the medical tool. When the magnetis removed with the handle portion (e.g., portion 1960), the reed switchopens and disables the medical tool. Other proximity switches toaccomplish the same function can also be used. The tool lock may also oralternatively disable the medical tool function once the tool lock isremoved from the medical tool (e.g., as would be required to remove themedical tool from the sheath). For example, the tool lock could have adirect wired connection to the medical tool (for example, within thetool portion 1212) which disconnects from the medical tool upon toolremoval. The medical tool could also include a proximity sensor in thetool portion 1212 which is disabled once the medical tool is removedfrom the sheath. For example, similar to that described above, a reedswitch completing a functional circuit in the medical tool could be heldclosed by a magnet in the tool lock. Removal of the tool lock would thenopen the reed switch and disable the medical tool. Other proximitysensors known in the art could also be utilized. Replacement of the toollock could re-enable the function; however, an additional reprogrammingof the controlling tool software may also be made necessary to resetfunction of the medical tool once the software detects an interruptionin the circuit. In a related scenario, the removal or breakage of handleportion (such as portion 1960) could interrupt a circuit in the toollock which is sensed by the medical tool and/or more specifically, thecontrolling tool software. Function could then be restored to the toolby repairing, replacing, or reprogramming the tool lock, and thereplacement and/or repair of the handle portion (such as portion 1960).

FIGS. 10A and 10B illustrates another embodiment of a system that hasmodular features to aid in reposing the device. In this embodiment,handle assembly 1506 may be disassembled through removal or breakage ofhandle rear component 1961 from the remainder of handle assembly 1506.This allows access to a tool lock (not shown but it could any tool lockdescribed herein) as well as hemostasis valve assembly 1950. Dependingon the configuration of the tool handle, the handle rear 1961 may beremoved from the tool in the proximal direction (without removal of thetool lock), or the tool lock may be accessed more easily to remove thetool lock than the prior embodiment where only the handle portion 1955was removed. In the present configuration hemostasis valve assembly 1950may be accessed to remove and replace the valve assembly. Alternativelythe valve assembly, including any of its individual components, could beremoved, disassembled, cleaned, repaired, and replaced. Repair may onlyinvolve replacement of hemostasis seal 1951 in the assembly 1950. Theseal could be of a slitted silicone or other soft polymeric compoundknown in the art, or any of the seals in this disclosure. The hemostasisvalve assembly preferably includes a luer fitting 1952 on its distal endsuch that it could simply be pressed into and out of a mating luerfitting in the handle. Alternative fittings can also be used.

The steerable sheath 1202 may also be adapted to allow the sheathportion 1208 to be separated from the handle assembly 1506. Similar toother modular components, this could allow removal for cleaning, repair,or replacement. Sheath 1202 may be fitted with tensile elements todeflect the catheter tip. Tensile elements similar to these areillustrated in FIG. 10B as elements 1970. The one or more tensileelements 1970 are preferably secured permanently to a fastener 1971,such as by a welding, soldering, crimping, swaging, or adhesive/epoxybonding process. If potting the ends in an adhesive/epoxy, the end ofthe tensile element is preferably formed into an enlarged ball, coil,loop, or other similar feature larger than the cross-section of thetensile element itself. Alternatively, the tensile element may bereleasably secured with a set screw or other mechanical fastener. Anenlarged welded ball end or a separate tube crimped to the proximal endof the tensile element may aid in mechanical capture of the tensileelement 1970 in the fastener 1971. The fastener 1971 is configured to beacted on by an engagement feature 1972 and linked to the steerableactuator 1520. The engagement feature 1972 comprises a portion 1972′ and1972″ each comprising a thread, one the reverse of the other. Theactuator 1520 comprises a dual thread, one the reverse of the other,such that when actuator 1520 is rotated, portions 1972′ and 1972″ of theengagement feature are driven in opposite directions thereby causing thesteerable section to deflect in one or another direction. The fastenermay be designed to be readily disconnected and reconnected to theactuator for rapid and cost-effective processing during reposing.Alternatively, the tensile elements may be removably connected directlyto the engagement feature without use of the fastener.

FIGS. 11A and 11B illustrate an alternative embodiment of an integratedmedical device (e.g., ultrasound) or system 1700 that includes anintegrated handle assembly, a steerable sheath, and a medical tool, andcan be repurposed using any of the methods herein. In system 1700, thehandle assembly 1703 is in operable communication with steerable sheath1702 and medical tool 1704, the handle assembly 1703 including a handlebody 1705 with an outer surface positioned to be gripped by a user, afirst actuator 1720 adapted to be moved relative to handle body 1705,and a second actuator 1780 adapted to be moved relative to handle body1705. Steerable sheath 1702 has a distal deflectable region (notlabeled) that is in operable communication with at least one pull wire.In some embodiments, medical tool 1704 is an elongate ultrasound devicewith a distal portion that comprises an ultrasound transducer, at leasta portion of the elongate ultrasound device is disposed within steerablesheath 1702, the elongate ultrasound device is in operable communicationwith second actuator 1780. First actuator 1720 is in operablecommunication with at least one pull wire such that actuation of firstactuator 1720 relative to handle body 1705 causes deflection of thedistal deflectable region of steerable sheath 1702.

Second actuator 1780 is adapted to be rotated relative to handle body1705 and is also adapted to be moved axially relative to handle body1705. Second actuator 1780 is in operable communication with theelongate medical device 1704 such that axial movement of the secondactuator relative to handle body 1705 causes axial movement of elongatemedical device 1704 (distal and proximal) relative to the distal end ofthe steerable sheath, and such that rotation of second actuator 1780relative to the handle body 1705 causes rotation of elongate medicaldevice 1704 relative to the distal end of the steerable sheath, as isshown as rotational movement “R” in FIGS. 11A and 11B.

Axial movement of the tool relative to the sheath, if the tool is anultrasound imaging tool, is generally desirable in that it improves theprobe's ability to image larger regions of the body after the probe hasbeen steered to a particular location and allows the operator to moreeasily refine the field of view once the probe has been steered to agenerally viable location.

System 1700 also includes optional tool lock 1755. Tool lock 1755 iscontained within handle assembly 1703 but coupled to second actuator1780. Tool lock 1755 and second actuator 1780 may be fitted withmagnets, for example, to engage one another. Alternatively, one of thecomponents could contain iron and the other a magnet. Tool lock 1755 isfirmly and releasably coupled to tool portion 1712 of medical tool 1704.Advancing distally or retracting proximally second actuator 1780 movestool lock 1755 distally or proximally, respectively. The resultingaxially movement of actuator tool 1755 causes axially movement ofmedical tool 1704. Similarly, rotation of second actuator 1780 relativeto handle body 1705 causes rotation of tool lock 1755, which causes therotation of medical tool 1704 (shown as rotation “R” in FIGS. 11A and11B). In this embodiment, the tool's axial movement (relative to thesheath) as well as its rotational movement (relative to the sheath) arelimited within a fixed range of motion. In one embodiment, in order toremove medical tool 1704 from the steerable sheath 1702 (such as duringrefurbishment), handle rear lip 1762 could be removed or broken toremove tool lock 1755 (and remainder of the tool portion 1712) fromhandle 1706. In addition, second actuator 1780 could be decoupled fromtool lock 1755. This may require custom fixtures to pry the coupledunits apart, or the use of a special tool to demagnetize or otherwisealter the polarity (temporarily at least) of either the outer coupler ortool lock. As described previously, the tool lock may contain a featureto disable the tool function when the magnet or other proximitycontroller is removed. Rear lip 1762 is an illustrative and optionalcomponent, and the handle assembly can have different parts.

FIGS. 12A-12C illustrate an embodiment of a system in which the medicaltool 1204 (which can also be any other medical tool herein) includes aplurality of electrical contacts 1992. FIGS. 12Ai and 12Aii illustratethe disassembled components. FIGS. 12Bi and 12Bii illustrate toolportion 1212 back loaded into the sheath portion 1208. FIG. 12Cillustrates proximal tool connector 1990 (which can be attached,directly or indirectly with an energy console) connected to tool portion1212 so the tool portion 1212 is in electrical communication withconnector 1990. Tool portion 1212 is fitted on the proximal end with aplurality of mating electrical contacts 1992. Tool 1204 contains adistal working end 1821 (e.g., ultrasound imaging tool) which is largerin diameter than the lumen of the tool portion 1212, an illustration ofwhich is shown in FIG. 12Bii. In this embodiment the outer dimension oftool portion 1212 and electrical contacts 1992 are sized to pass througha lumen of the sheath portion 1208, but the distal working end 1821 istoo large to pass through the lumen. As a result, assembly of the toolthrough the sheath portion 1208 requires the proximal end of the toolportion 1212 be advanced through the distal tip of the sheath andadvanced proximally until the electrodes exit the proximal end of thesheath handle 1206. This construction helps minimize the outer dimensionof the sheath portion 1208 such that it is not necessarily larger thanthe distal working end 1821. In certain uses the distal working end mayneed to be at a maximum allowed dimension to accommodate electroniccomponents and their connections, or, in certain applications, minimizethe density of electrical current or acoustic energy to minimizeoverheating or cavitation of the tissue. The proximal electricalcontacts 1992 may be discrete electrically conductive surfaces (e.g.,discs, bars, strips, spheres, etc.), or circumferential or partiallycircumferential rings. In a preferred embodiment, the contacts areformed from the exposed conductive material of an otherwise insulatedflex circuit (e.g. insulation is not disposed over the exposedconductive material). The mating contacts 1991 in the connector may besimilarly designed to make contact. The contact surface may be annularor flat and preferably is spring loaded or otherwise mechanicallycompressed to make secure contact. The handle assembly in FIGS. 12A-Ccan be any of the handle assemblies herein; the steerable sheath can beany of the steerable sheaths herein; and the medical tool can be any ofthe medical tools herein. The front loading assembly can be used duringthe assembly of any system herein.

FIGS. 13A-13C illustrate an exemplary proximal portion of a system, andwhich can be the proximal portion of any of the systems herein. Asillustrated in FIG. 13A, proximal contacts 1992 of the medical tool maybe press fit into connector 1990 against the contacts 1991.Alternatively, as illustrated in FIG. 13B, connector 1990′ can beadapted to open up to receive contacts 1991 before it is clamped downover contacts 1991, as shown in the closed configuration of FIG. 13C.The connector 1990′ can be sealed with seal 1995 during manufacture.Seal 1995 may comprise, but is not limited to, a hydrogel, a wax, asilicone ring or gasket, or other means and combinations describedpreviously in this disclosure. To repose the device, the connector 1990′contact must be broken or carefully disassembled to remove the shaft oftool 1212 in the distal direction through the sheath (such as asteerable sheath). Disassembly of seal 1995 may be accomplished byheating and melting the wax or other meltable substance, dissolving adried material in an aqueous solution, and/or swelling a silicone withheptane or similar chemical compound.

FIGS. 14A-14B illustrate a exemplary system similar to that of FIGS.13A-13C with the exception that the connector 1990″ contains an innerfeature 2000 designed to stably interface with and enclose tool lock1955 attached to tool portion 1212. FIG. 14A illustrates the system justbefore connection of the connector 1990″ to the tool portion 1212, andFIG. 14B shows a completed connection. While tool lock 1955 isillustrated just distal to the proximal tool contacts 1992, it couldalso be configured on the proximal side of the contacts, with acorresponding inner feature 2000 location proximal to the connectorcontacts 1991. As described previously, the tool lock may contain afeature to disable the tool function when the magnet or other proximitycontroller is removed. In this embodiment, the disabling feature mayalternatively be built into the connector 1990″, particularly within theinner feature 2000, where the circuit connection in the cable leadingback to a control console is dependent on the state of the disablingfeature. Assembly and disassembly of the portion of the connectorcontaining feature 2000 could be accomplished by the means describedpreviously for the connector 1990 in FIG. 13, the handle portion of FIG.8, or the rear handle of FIG. 10. The handle assembly in FIGS. 14A-B canbe any of the handle assemblies herein; the steerable sheath can be anyof the steerable sheaths herein; and the medical tool can be any of themedical tools herein.

In a variation of the embodiment in FIGS. 14A and 14B, the assembly oftool 1212 may require the “back loading” of tool 1212 through the distalend of the steerable sheath portion 1208, as described in the embodimentof FIGS. 12A-12C wherein the outer dimension of the tool and theelectrical contacts are sized to pass through the lumen of the sheathportion, but the distal working end may not pass. In this embodiment ofFIGS. 14A and 14B, the tool lock must be assembled after back loadingthe tool. During reposing, the tool lock would need to be removed toremove the tool 1212 from the sheath portion 1208, and repaired and/orreplaced after cleaning and re-back loading the tool 1212 through thesheath portion 1208. In an alternate version of the embodiment, the tool1212 may be assembled by “front loading” an insertion of the distal tipthrough the proximal handle end of sheath 1202. In this alternateembodiment of FIGS. 14A and 14B, tool lock 1955 does not necessarilyneed to be removable from the tool 1212.

As illustrated in FIGS. 14A-B, the clamping action of inner feature 2000over tool lock 1950 results in a mechanical engagement of the twofeatures such that axial translation and torque may be transferred fromthe connector 1990″ to the tool 1212. This may provide the user with amore convenient means of gripping the tool 1212 to manipulate itsposition relative to the sheath 1202.

As illustrated in the exemplary system of FIG. 15, a separate torquedevice 2005 can be attached to the tool 1212 to provide a similarability as above to translate and torque the tool 1212 relative tosheath 1202, but without the need to make a connection to connector1990, as previously described in FIGS. 14A and 14B. The torque device2005 may also be engaged over tool lock 1950 to provide enhancedmechanical engagement. Torque device 2005 could also serve a purposesimilar to the inner feature 2000 in that tool function is dependent onthe presence of the torque device 2005. As previously described in theembodiment of FIGS. 12A-12C, the torque device could be assembled ontothe tool 1212 such that removal of the tool 1212 from the sheath 1202 isnot possible without breaking the torque device and/or tool 1212, orwithout the use of a custom reposing process to remove the torquedevice. The handle assembly in FIG. 15 can be any of the handleassemblies herein; the steerable sheath can be any of the steerablesheaths herein; and the medical tool can be any of the medical toolsherein.

The embodiment of FIGS. 16A-C illustrates an exemplary medical toolwhere tool portion 1212 comprises an outer member 2010 and an inner leadassembly 2011. The inner lead assembly further includes a distal workingend 1821 and proximal electrical contacts 1992. The outer member 2010may be assembled and disassembled from the inner lead assembly as partof the reposing process. The outer member 2010 can be a tubularstructure capable of transmitting torque via, for example, a braidedcomposite construction. Outer member 2010 is reversibly sealed andsecured to the inner lead assembly at locations 2015 and 2013 usingprocesses previously described in this disclosure. FIG. 16B shows alarger view of the encircled region in FIG. 16A. FIG. 16C shows innerlead assembly 2011, distal working end, and proximal end removed fromouter member 2010. The handle assembly in FIGS. 16A-C can be any of thehandle assemblies herein; the steerable sheath can be any of thesteerable sheaths herein; and the medical tool can be any of the medicaltools herein.

The disclosure below relates generally to electrical connections andcontacts in a medical device, optionally an ultrasound probe if nototherwise specified. The disclosure that follows can apply to any of thesystems, or aspect of the systems, herein. The electrical connections,contacts, device, and methods can be integrated into any of the systemsabove, such as, without limitation, the handle assembly in FIG. 11.

One aspect of the disclosure includes methods of disassociating at leasta portion of the system from other components, optionally as part of areposing process. In some embodiments the medical tool includes one ormore electrical contacts that are coupled to other electrical contacts,which are in electrical communication with an energy console, andexamples of consoles are known in the ultrasound art.

FIG. 17 illustrates merely a portion of an exemplary medical tool, suchas an ultrasound probe, that can be electrically coupled directly orindirectly to an energy console, such as an ultrasound console.

The embodiment shown in FIG. 17 can be used in a manner similar inconcept to the embodiment illustrated in FIGS. 12A-C, in that reposingthe device involves disconnection of one or more proximal electricalcontacts and moving the tool portion distally out of the distal end ofthe sheath portion. In this embodiment tool portion 1212 comprises atleast a tool outer sheath or member 2010, distal working end 1821 (whichcan include at least one ultrasound transducer), and conductor bundle2020. The conductor bundle 2020 extends from the distal working end1821, through the tool outer member 2010 to a proximal connector (theconnector and handle mechanism are not shown in FIG. 17 for clarity). Insome embodiments the medical tool is used for ultrasound imaging,optionally where the distal working end 1821 comprises a two-dimensional(2D) array of piezo electric components mounted on an ASIC (applicationspecific integrated circuit).

FIG. 18 illustrates a merely exemplary proximal end of a medical device(the medical device is shown on the right), and in this embodiment themedical device is an ultrasound probe. The proximal end 2015 of themedical device is adapted to be electrically coupled to connector cable270, which is directly or adapted to be indirectly electrically coupledto an energy console, such as an ultrasound energy console. Asillustrated in FIG. 18, conductor bundle 2020 extends from a distalregion of the medical tool (distal region not shown) into a proximalconnector 2015 within which is housed a rigid or flexible printedcircuit board (“PCB”) 2030. The connector bundle 2020 includes aplurality of contacts 2024 (examples of which are described below) thatare attached to PCB board contacts 2031. Each individual trace from eachcontact 2031 is linked to individual exposed contacts 2050 on anotherportion, optionally more proximal, of the PCB. The individual PCB tracesmay also pass through other useful circuitry on the PCB. The exposedcontacts 2050 are configured for a mechanical mating for electricalconduction to similar contacts 2060 on mating connector cable 2070,similar in concept to the proximal tool connector 1990 describedpreviously, which links the tool 1204 to a user-interface console.Proximal connector 2015 can be incorporated into any of the systems,handles, steerable sheaths, medical tools, etc., herein, such as thatshown in FIGS. 11A and 11B.

FIGS. 19A and 19B illustrate an exemplary conductor strip (also referredto herein as a flexible circuit strip) 2021 that can be included in anyof the conductor bundles herein. The embodiment in FIGS. 19A and 19B isan example of a conductor strip that can be included in bundle 2020 fromFIGS. 17 and 18. The embodiment in FIGS. 19A and 19B can be incorporatedinto any other system herein.

As shown in FIGS. 19A, 19B and 19G, conductor bundle 2020 comprises aplurality of flex circuit strips, including multi-trace strips 2021, aswell as conductive strips for grounding 2022 and shielding 2023 (only aportion of which are shown). Each multi-trace strip comprises aplurality of conductive traces 2025, which can be seen clearly in FIGS.19B, 19C and 19D. The number traces 2025 in FIGS. 19D-19G is twelve, andthe number of traces in FIGS. 19A-19C is sixteen, and they are bothexemplary as to the number of traces 2025 that can be used. Each strip2021 can be approximately 0.072″ wide and 0.0022″ thick, and canoptionally comprise sixteen 0.0022″ wide×about 0.0007″ thick conductive(e.g., copper) traces, each spaced approximately 0.0022″ apart. Thetraces are disposed on an insulating substrate layer 2027, such as apolyimide substrate, and the traces can be at least partly covered by acover layer 2026, such as a photoimageable film cover (“PIC”) layer orother dry film solder mask (DFSM) or other similar material. The coverlayer generally extends along most of the bundle, except at discretelocations in proximal and distal regions for electrical coupling. Inother embodiments, the strip 2021 is approximately 0.055″ wide andcomprises twelve conductive traces (see FIGS. 19D-19G). In otherembodiments, the strip 2021 is approximately 0.037″ wide and compriseseight copper conductive traces. The outer strips 2022 and 2023 used forgrounding and shielding may have a similar construction and dimensionexcept they can comprise a single full width strip of copper. Asoptimized for a 2D piezo array, a stack of approximately seven 16-tracestrips 2021 would be required (or nine 12-trace, or fourteen 8-trace),along with one each of strips 2022 and 2023 on each side of the stack ofmulti-trace strips. FIG. 19E illustrates a portion of an exemplarybundle 2020 with nine strips 2021 stacked together. FIG. 19F illustratesa portion of the bundle that includes nine strips 2021 stacked, as wellas ground strip 2022 and shield strip 2023 (only those on top arelabeled). The complete bundle may optionally be held together with a,for example without limitation, about 0.001″ wall thickness shrink tube,such as the tubing 2028 in FIG. 19G. The flex circuit dimensions andnumber of traces discussed above are for a particular configuration of apiezo-electric array (and/or an ASIC controller thereof) and may bevaried depending on how the number and size of array elements areoptimized for the particular application.

The proximal end of each flex circuit strip has the conductive material(e.g., gold-plated copper) exposed over a length of approximately, forexample, 3 mm through removal of the cover layer 2026 at location 2024.Location 2024, and other exposed locations described herein, isgenerally referred to as a “contact.” It is understood that when used inthis context, the contact actually includes a plurality of separatedconductive traces (such as shown in region location), each of which isadapted to be in electrical communication with its own correspondingconductive element. “Contact” is therefore not limited to mean only asingle electrical connection between two conductive elements. While FIG.19A shows a plurality of exposed regions 2024, the embodiment in FIG.19A will first be described herein as if there is only one exposedregion (i.e., region 2024 at the proximal end). The strip 2021 can bemade to create an electrical connection to matching exposed contacts2031, shown in FIGS. 20A-C, for conductive traces on the PCB 2030. Insome embodiments, sixteen individual traces, sized and spaced to matchsixteen traces in the multi-trace strip 2021, would be provided within agiven contact 2031. An ACF (anisotropic conductive film), soldering,conductive adhesive, mechanical connection, or any combination of thesemay be used to achieve a suitable electrical connection (electricalcoupling) between the strip traces and the PCB contacts.

As illustrated in FIG. 20A and FIG. 20B, the plurality of flex circuitstrips (not all are illustrated) preferably have a staggered length suchthat the exposed locations 2024 (each strip has an exposed location 2024at its proximal end) are attached to the PCB 2030 at contacts 2031provided in a similarly staggered length. One or more of an array(preferably a linear array) of contacts 2031 could all be on one side ofthe PCB, or a second array (or array plurality) 2031′ (see FIG. 20B)could be provided on the underside of the PCB. Those on the other sideof the PCB could allow exposed regions 2024 of other strips to beattached to the other side of the PCB, creating more room and connectionoptions.

As part of any of the reposing processes described herein, thestrip-to-PCB connection may be disconnected to allow the entire toolportion 1212, which includes the now disconnected conductor bundle 2020(disconnected from the PCB), to be slideably removed out of the distalend of the sheath portion 1208, as illustrated in the direction of thearrow shown in FIG. 20C. Once removed, the outside of the tool portion1212 and at least the inner and outer surfaces of the sheath portion1208 may be cleaned and decontaminated. The tool portion 1212 may thenbe back-loaded proximally through the sheath portion 1208 until thedistal working end 1821 is properly seated in relation to the distal endof sheath portion 1208, as is described in more detail herein. Theproximal ends of strips 2021, 2022, and 2023 are then reattached to theexposed contacts 2031 and 2031′, which can be the same contacts ordifferent contacts. In the case of ACF bonding, the same ACF materialmay be used and/or it may be cleaned and new ACF material applied priorto bonding. The connection integrity and ultrasound performance may thenbe tested to verify acceptable performance. This reposing process can beused on any of the systems herein.

One aspect of the disclosure herein is a method of disassembling asystem that has already been exposed to a bodily fluid of a subject(e.g., exposed to a blood environment, an esophagus, etc.), the systemincluding a medical tool such as an ultrasound probe, a steerable shaft,and a handle assembly. The method can include providing a handleassembly, a steerable sheath that has been exposed to a bodily fluidenvironment of a subject, and an ultrasound probe that has been exposedto the bodily fluid environment of the subject, the handle assembly inoperable communication with the steerable sheath and the ultrasoundprobe, the handle assembly including a handle body with an outer surfacethat can be gripped by a user, a first actuator adapted to be movedrelative to the handle body, and a second actuator adapted to be movedrelative to the handle body, the steerable sheath having a distaldeflectable region that is in operable communication with at least onepull wire, wherein the first actuator is in operable communication withthe pull wire such that actuation of the first actuator relative to thehandle body causes deflection of the distal deflectable region, andwherein the second actuator is adapted to be rotated relative to thehandle body and is also adapted to be moved axially relative to thehandle body, and wherein the second actuator is in operablecommunication with the ultrasound probe such that axial movement of thesecond actuator relative to the handle body causes axial movement of theultrasound probe relative to the distal end of the steerable sheath, andsuch that rotation of the second actuator relative to the handle bodycauses rotation of the ultrasound probe relative to the distal end ofthe steerable sheath, the ultrasound probe having a distal portion thatincludes an ultrasound transducer, the distal portion extending furtherdistally than a distal end of the steerable sheath and having an outerdimension greater than a dimension of a lumen of the steerable sheath inwhich the probe is disposed, the ultrasound probe further including aflexible circuit strip, the flexible circuit strip comprising aninsulating substrate, a plurality of conductive traces disposed on andextending along the insulating substrate, a portion of each of theplurality of conductive traces covered by an insulation member, and aportion of the plurality of conductive traces not covered by theinsulation member, the portion of the plurality of conductive tracesthat are not covered by the second insulation layer defining a probecontact, the probe contact electrically coupled to an electrical contacton a printed circuit board, where the printed circuit board or any ofthe printed circuit boards herein can be a flexible circuit board. Anexemplary system that could be used in this method is shown in FIGS. 11Aand 11B. The “providing” step above (or in any other method herein)simply requires that the system be available for the following methodsteps, and does not require an act of providing or giving the system toanother person or entity. Thus, a system simply sitting on a tabletophas been “provided” in this context.

The method of disassembly further includes electrically disconnectingthe probe contact from the electrical contact on the printed circuitboard, which is described herein.

The method of disassembly further optionally includes moving theultrasound probe distally relative to the steerable sheath and out ofthe distal end of the steerable sheath, such as is illustrated in FIG.20C.

The method of disassembly can optionally further include, but does notnecessarily need to include, cleaning at least a portion of theultrasound probe, the portion comprising a region of the ultrasoundprobe that was, before the moving step, not extending out of the sheath,and optionally disposed within the handle assembly. For example, inFIGS. 11A and 11B, a portion of the medical device is disposed withinthe handle assembly.

The method of disassembly can optionally further include, but does notnecessarily need to include, at some time after the optional cleaningstep, electrically coupling the probe contact to either the printedcircuit board or a different printed circuit board.

The method of disassembly can further comprise (and may in factrequire), at some time before the moving step, releasing the ultrasoundprobe from a releasably secured engagement with a handle assemblycomponent. In some embodiments the ultrasound probe will not be able tobe removed from the handle assembly without first doing this. Releasingthe ultrasound probe from a releasably secured engagement with a handleassembly component can comprise releasing the probe from a releasablysecured engagement with a handle assembly component that is in direct orindirect operable communication with the second actuator. For example,FIG. 11A illustrates a medical device releasably secured to handleassembly component 1755, which in that embodiment is described as a toollock. A method of disassembly can include, prior to the moving step,releasing the ultrasound probe from a releasably secured engagement withtool lock 1755, which is in this embodiment is also an example of ahandle assembly component that is in direct or indirect operablecommunication with second actuator 1780.

In some embodiments herein, an ultrasound probe and handle assembly areadapted so that the probe can be moved axially (distally and proximally)relative to the sheath. Bodily fluids such as blood can enter into thespace between the probe and sheath, thus necessitating cleaning beforereuse of the usually relatively expensive probe. In some embodiments,the distal tip of the ultrasound probe has a larger outermost dimensionthan the distal end of the steerable sheath. This can be desirable as away of minimizing the footprint of the sheath within a patient. Afterthe probe has been used and exposed to a bodily fluid, the probe thuscannot be retracted proximally within and relative to the sheath todisassemble the probe from the sheath. The probe must then be removeddistally relative to and from the sheath in order to repurpose theprobe. Because the probe is attached at its proximal end to some type ofconnector (e.g., directly or indirectly to an ultrasound console), theprobe must therefore first be taken out of electrical communication withthe connector prior to moving the probe distally relative to the sheath.

In an alternate embodiment, during a reposing process it may be moreefficient and/or reliable to not re-attach the original exposedlocations 2024 of the conductive strips 2021 (and, if necessary, 2022and 2023). In this case, as illustrated in FIGS. 19A and 19B, each strip2021 may be provided with a plurality of exposed locations 2024, 2024′,2024″, etc. (each optionally about 3 mm in length) staggered in a distaldirection along the strip length. Thus, the original location 2024, aswell as a section of layer 2026, may be trimmed off or removed usingother techniques, and the next most proximal location 2024′ can be usedfor the new connection attachment. This process can also be repeated forfuture reposing processes until all of the exposed locations are used.This would also serve to limit the number of reuses of the device. Theexposed but not-in-use locations on the strips can also be protecteduntil ready for use with a, for example, peel-away insulating low tackadhesive strip. In other embodiments, this protective layer could be apaste, an adhesive, or a cured polymer having sufficient dielectricproperties and conformability to insulate adjacent exposed conductorswithin a given strip. The material is preferably reversibly adhered suchthat it can be easily peeled or dissolved away from the exposedconductors without damaging the conductors. In some embodiments acovering layer that is disposed over the traces can be ablated away(e.g., using a laser, sandblasted, or sanded) to reveal an exposedregion of traces, which can then be used as a contact location.

In some embodiments alternative to that shown in FIGS. 19A and 19B, thestrip can first be attached with the only exposed region beingproximal-most region 2024, and wherein the cover layer 2026 extendsdistally without any discontinuities in layer 2026. After a first use,region 2024 can be removed. To expose another conductive region, aportion of the now-proximal end of layer 2026 can be removed, such as byablation, or if the layer 2026 is a peel-away section, peeling it away.This process can be repeated as needed after each use to create newexposed conductive regions.

In embodiments in which the flex circuit strips are trimmed or removedusing any suitable technique to attach the next exposed element of theflex circuit strips to the PCB, it may be necessary to advance thestrips forward to establish the electrical connection. This may bedifficult or impossible if the strips are confined and immovable withina tube, or otherwise securely housed, up to the PCB. As illustrated inthe exemplary embodiment in FIG. 21, to allow extra length to beadvanced relative to the tube, a conductor bundle 2020 (which can be thesame as bundles 2020 herein or different bundles) could be reversiblyspooled or wrapped around a spool 2035 comprising a rod, tube, spindleor similar rotatable structure, for a length suitable to advance out allexposed elements. Before winding, the conductor bundle could be firstpassed through a slot passing transversely through the central axis, orthe bundle could be wound from one end of the outer surface of the spoolto the other. Thus after trimming off one contact set, the conductorsare unwound off the spool to make the next set of connections on the PCB2030. The spool preferably has a central axis which could be mounted onthe distal end of the PCB or within a mechanism just distal to theboard, and secured within the proximal connector 2015. The spool mayalso serve to protect the connections to the PCB from being strained dueto tensile or twisting forces applied to the flex conductor bundle. Toprevent premature unwinding, the spool could be fitted with a keyedfeature reversibly connected to the PCB or other location within theproximal connector or connector housing itself.

If removing the original connection to the PCB at connectors 2031compromises the integrity of these connections, the PCB could include aplurality of arrays of redundant connectors 2031′, 2031,″ etc. to whichconnections can be made with each reposing cycle of the device.

In another embodiment, the PCB could simply be replaced with a newidentical PCB to which the exposed ends 2024 (or 2024′, etc.) of theflex circuit strips could be attached.

FIG. 22 illustrates another embodiment in which exposed flex circuitends (2024 or 2024′) could be attached to a disposable mini-PCB element2040, which has the same connection 2031 on one side, but larger exposedconnections 2041 on the opposite side, linked through traces in themini-PCB, suitable for a reusable mechanical connection to the PCB 2030.The mechanical connection from connections 2041 on the mini-PCB 2040 ismade against matching exposed mechanical connections 2042 on the PCB2030. Spring clips or other suitable holding mechanisms could beintegrated into the PCB to hold the mini-PCB contacts against those onthe PCB. Each individual trace from each contact 2042 is linked toindividual exposed contacts 2050 on another portion, preferably moreproximal, of the PCB. The individual PCB traces may also pass throughother useful circuitry on the PCB. The exposed contacts 2050 areconfigured for a mechanical mating for electrical conduction to similarcontacts 2060 on a mating connector cable (e.g., cable 2070) which linksthe medical tool to the console. During the reposing process, themini-PCB may be unclipped from the PCB and the flex circuit detached orclipped away from (as previously described) the mini-PCB. After removal,cleaning, and reassembly of the tool in the sheath, the flex circuitsmay then be reattached to new mini-PCBs that are re-connected to theoriginal PCB.

To allow access to the PCB 2030, and spool 2035 if applicable, theproximal connector (e.g., proximal connector 2015) can be fitted with aremovable housing that has a custom design for it to mate with otherportions of the connector and/or the PCB 2030 and/or the spool 2035.Optionally, to remove this housing completely will require breaking thehousing thereby rendering it non-functional, requiring replacement priorto continued use.

Distal to the spool, the conductor bundle 2020 is optionallyirreversibly secured within the tool outer member 2010. The tool outermember 2010 preferably also extends proximal to the handle 1206. Afterdisconnection of the flex circuit from the PCB, to allow the assembly ofthe tool outer member 2010 and conductor bundle to be removed from thehandle 1206 and sheath portion 1208, the assembly is preferablyslideable within any tubular connection line between the handle 1206 andproximal connector 2015. Reversible seals, similar to those previouslydescribed herein, could also be used between the tool outer member 2010and tubular connection line.

The construction of the medical tool 1212 may be optimized to minimizethe diameter and to provide optimal torque response of the distalworking end (e.g., working end 1812). In some embodiments, the flexcircuits are routed through an inner lumen of tool member 2010, similarto that illustrated in FIG. 16B.

FIG. 23 illustrates the cross-section of the bundled stack 2020 insidemember 2010. In this embodiment, the ˜0.072″ width of the flex circuitbundle is optimized for the width of the ASIC to which the piezoelectriccomponents are mounted. Taking into account shrink tubing around thestack, the stack dimensions are approximately 0.028″ thick×0.085″ wide.The inner lumen of the tool member 2010 would require an innerdimension, in at least one dimension, of approximately 0.089″. Thisdimension then drives the outer dimension of the member 2010 which alsoimpacts the inner and outer dimensions of the sheath portion 1208.

While the conductor bundle 2020 may simply be routed through a circularinner lumen of the tool member 2010 as shown in FIG. 23, it mayalternatively be constrained within a non-circular lumen such as isillustrated in FIG. 24. In this configuration, additional “D” lumens arealso provided such that additional stiffening members 2100 may be addedto create a more uniform bending stiffness in a variety of directionssuch that the stiffness along the long axis of the conductor bundle 2020does not dominate the shaft stiffness. This will serve to minimize“whipping”, or sudden jerks in torque response, as the tool member 2010is torqued.

FIG. 25 illustrates an embodiment, similar to that shown in FIG. 24,where different size lumens are provided to accept stiffening members2101 and 2102. These may also serve to create a uniform bendingstiffness. The tool member 2010 is preferably constructed with an outerbraid of wire and/or fiber which is heat laminated with a jacket ofthermoplastic polymer (e.g., Pebax in durometers ranging 25 D to 72 D orother suitable catheter material known in the art).

The embodiment of FIG. 26 illustrates a “D” shaped member 2103 appliedto either side of the flex circuit bundle 2020. This creates a uniformlyround member which can be held in place with a thin wall (˜0.001″ thick)heat shrink tube. In one embodiment, the assembly may then be insertedinto a tool member shaft 2010. In another embodiment, the tool membershaft can be constructed directly around the conductor bundle. Forexample, to improve torque response and minimize the size of the tool1212, multiple fibers and/or metal wire (round or ribbon shaped) may bebraided directly over the conductor bundle 2020. A jacket of polymer(such as Pebax in a range of durometers from 25 D-72 D, or other commoncatheter materials) may be laminated with heat to reflow the polymerover the entire braid to form a uniform member. A polymer layer similarto the jacket may also be laminated over the conductor bundle beforebraiding to improve the reflow penetration of the polymer into the braidduring heat lamination.

For the embodiments of FIGS. 23-26, the luminal space between theconductor bundle and inner diameter of shaft 2010 could be used to routepull wires used to steer the tool 1212 independent of the steerablesheath 1202. The stiffeners themselves could be used as pull wires, orreplaced with more traditional pull wires (e.g., round and/or flattenedstainless steel or nitinol, or a cable braid of these materials). Thepull wires could be fixed at the distal end of the shaft 2010 andactuated in a manner similar to other embodiments described herein.

In an alternative embodiment, illustrated in FIG. 27 and showingexemplary bundle 2020, each flex circuit strip could be made withapproximately half the number of traces, and thus have approximatelyhalf the width (˜0.037″ wide). For the specific embodiment describedabove, this requires doubling the number of multi-trace circuits toapproximately 14. This, in combination with the ground and shieldingflex circuits, creates as stack of about 17 flex circuits. The resultingwidth and height are more even, close to 0.042″ each with the heatshrink. This allows a more efficient use of space within the lumen ofmember 2010 and improves the uniformity of the torque response. Asdescribed for FIG. 26, the stack could be inserted into a tubular shaftor the shaft constructed around it with a braid and jacket. Otherconfigurations are also contemplated between those illustrated in FIG.23 and FIG. 27 for optimization with the transducer assembly. Forinstance, the width of the flex bundle with heat shrink may be limitedto approximately 0.068″ with a stack of 13 flex circuits beingapproximately 0.031″ thick.

In another embodiment, the ground and/or shield strips are replaced byseparate braids or winds of conductor wire (individually insulated ornot insulated) around the bundle of flex multi-trace flex circuits. Ifthe ground and shield conductors are not insulated, an insulatingpolymer layer may be added between the braids of ground and shieldingconductors. This conductor braid may be provided in addition to orinstead of the braid of fibers and/or metal wire/ribbon. Insulatedconductors may also be woven into a braid of fibers and/or metalwire/ribbon to optimize torque response of tool 1212 and minimize thenumber of braided layers.

In another embodiment, the conductor bundle 2010 may be twisted toprovide a more balanced cross-section along the majority of the lengthof the tool 1212. The conductor bundle may be run straight in the distalfew centimeters to facilitate connection to the distal working end 1821.

In another embodiment, the individual flex circuit strips may be wrappedaround the outer dimension of an elongated central core member. The coremay be a solid or tubular construction of a polymer or metal, or acomposite braid. The wraps may be a group of parallel strips in onelayer, but may be wrapped in multiple layers. Preferably, layers arewrapped in alternating directions to optimize torque of the unit. Thewrapped strips are preferably laminated against the central core with apolymer jacket. In other embodiments the inside of the jacket may have aloose clearance with the conductor strips to allow some flexuralmovement for strain relief of the strips. A braid over this jacketfollowed by lamination of a second jacket over the braid may also beprovided. Similar to the embodiment described above, the ground and/orshield conductors may be replaced with braided or wound conductors.

As used herein, “cleaning” can refer to any type of cleaning, such aswithout limitation: cleaning an interior of an outer shaft using aflushing system of cleaner and/or disinfectant and optionally mechanicalscrubbing with small brushes; mechanical cleaning (e.g., wipes, brushes)an outer portion of an outer shaft and/or outer portion of a medicaldevice shaft (e.g., ultrasound probe) with a cleaner/disinfectant, andoptionally submerging the shaft in an ultrasound bath ofcleaner/disinfectant for a specified period of time. “Cleaning” as usedhere does not refer to a specific cleaning process, but rather refers tothe general idea of cleaning an object.

Regardless of the reference number with which they are labeled, any ofthe handle assemblies, medical tools, steerable sheaths, and electricalconnections herein can be used together in a system in any combinationwith each other.

Any of the technology, including ultrasound and steering technology, inany of the following U.S. patent references may be incorporated into anyof the medical tools, devices, systems, or methods of use thereofherein, the disclosures of which are incorporated by reference herein:U.S. Pat. Nos. 6,100,626, 6,537,217, 6,559,389, 7,257,051, 7,297,118,7,331,927, 7,338,450, 7,451,650, 7,451,650, 7,527,591, 7,527,592,7,569,015, 7,621,028, 7,731,516, 7,740,584, 7,766,833, 7,783,339,7,791,252, 7,791,252, 7,819,802, 7,824,335, 7,966,058, 8,057,397,8,096,951, 8,207,652, 8,207,652, 8,213,693, 8,364,242, 8,428,690,8,451,155, 8,527,032, 8,659,212, 8,721,553, 8,727,993, 8,742,646,8,742,646, 8,776,335, 8,790,262, 8,933,613, 8,978,216, 8,989,842,9,055,883, 9,439,625, 9,575,165, 9,639,056, and 20080287783.

What is claimed is:
 1. A method of disassembling a system exposed to abodily fluid of a subject, the system including an ultrasound probe, asteerable shaft, and a handle assembly, comprising: providing a handleassembly, a steerable sheath that has been exposed to a bodily fluidenvironment of a subject, and an ultrasound probe that has been exposedto the bodily fluid environment of the subject, the handle assembly inoperable communication with the steerable sheath and the ultrasoundprobe, the handle assembly including a handle body with an outer surfacethat can be gripped by a user, a first actuator adapted to be movedrelative to the handle body, and a second actuator adapted to be movedrelative to the handle body, the steerable sheath having a distaldeflectable region that is in operable communication with at least onepull wire, wherein the first actuator is in operable communication withthe pull wire such that actuation of the first actuator relative to thehandle body causes deflection of the distal deflectable region, andwherein the second actuator is adapted to be rotated relative to thehandle body and is also adapted to be moved axially relative to thehandle body, and wherein the second actuator is in operablecommunication with the ultrasound probe such that axial movement of thesecond actuator relative to the handle body causes axial movement of theultrasound probe relative to the distal end of the steerable sheath, andsuch that rotation of the second actuator relative to the handle bodycauses rotation of the ultrasound probe relative to the distal end ofthe steerable sheath, the ultrasound probe having a distal portion thatincludes an ultrasound transducer, the distal portion extending furtherdistally than a distal end of the steerable sheath and having an outerdimension greater than a dimension of a lumen of the steerable sheath inwhich the probe is disposed, the ultrasound probe further including aflexible circuit strip, the flexible circuit strip comprising aninsulating substrate, a plurality of conductive traces disposed on andextending along the insulating substrate, a portion of each of theplurality of conductive traces covered by an insulation member, and aportion of the plurality of conductive traces not covered by theinsulation member, the portion of the plurality of conductive tracesthat are not covered by the insulation member defining a probe contact,the probe contact electrically coupled to an electrical contact on aprinted circuit board of the system; electrically disconnecting theprobe contact from the electrical contact on the printed circuit boardof the system; moving the ultrasound probe distally relative to thesteerable sheath and out of the distal end of the steerable sheath;cleaning at least a portion of the ultrasound probe, the portioncomprising a region of the ultrasound probe that, prior to the movingstep, does not extend outside of the steerable shaft and optionallycomprises a region that, prior to the moving step, was disposed withinthe handle assembly; and after the cleaning step, electrically couplingthe probe contact to either the printed circuit board of the system or adifferent printed circuit board.
 2. The method of claim 1, wherein theultrasound probe comprises a plurality of flexible circuit strips, eachof the plurality of flexible circuit strips comprising an insulatingsubstrate, a plurality of conductive traces disposed on and extendingalong the insulating substrate, a portion of each of the plurality ofconductive traces covered by an insulation member, and a portion of theplurality of conductive traces not covered by the insulation member, theportion of the plurality of conductive traces that are not covered bythe insulation member defining a probe contact.
 3. The method of claim1, further comprising, before the moving step, releasing the ultrasoundprobe from a releasably secured engagement with a handle assemblycomponent.
 4. The method of claim 3, wherein releasing the ultrasoundprobe from the releasably secured engagement with the handle assemblycomponent comprises releasing the probe from the releasably securedengagement with the handle assembly component that is in direct orindirect operable communication with the second actuator.